| 丁正磊,丛骆骆,吴彬.药物临床试验机构监管常见问题及对策研究[J].中国药事,2018,32(3):299-304 |
| 药物临床试验机构监管常见问题及对策研究 |
| Study on the Common Problems of and Countermeasures for the Supervision of Institutions for Drug Clinical Trial |
| 投稿时间：2017-12-26 |
| DOI：10.16153/j.1002-7777.2018.03.001 |
| 中文关键词: 药物临床试验机构 监督检查 问题 对策 |
| 英文关键词: institutions for drug clinical trial supervision and inspection problems countermeasures |
| 基金项目: |
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| 中文摘要: |
| 药物临床试验是新药研发过程中的重要环节，其操作的规范程度直接关系到药物研究数据的科学性、真实性和完整性。本文通过对北京市药物临床试验机构监督检查中发现问题的归类与分析，研究加强药物临床试验机构监管、提高监管效能的措施及对策。 |
| 英文摘要: |
| Clinical trial is an important step of new drug development and the compliance level of the clinical trial directly impact the scientificity, authenticity and integrity of the data in drug research. Based on the classifcation and analysis of the common problems which were identifed during the supervision and inspection of institutions for drug clinical trial in Beijing, this article is to study how to strengthen the supervision of the institutions for drug clinical trial and the solutions and countermeasures to improve the supervision. |
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